Search Results for: Nota 87

Objectives
The Idea, Development, Evaluation, Assessment and Long-term follow-up (IDEAL) framework was designed to improve the quality of surgical research and evaluation of surgical innovation. It has become a widely cited tool for evaluating innovative devices and procedures, yet challenges remain concerning the definition and reporting of incremental innovative modifications, hindering evolution and evaluation of innovations and potentially risking patient safety. This systematic review examined IDEAL studies to identify such modifications and establish recent practices around modification reporting to inform the development of future guidance to facilitate safe, transparent and efficient surgical innovation.

Design
Systematic review and thematic synthesis of studies reporting surgical innovation.

Data sources
Web of Science and Scopus were searched in July 2023 using citation tools to identify studies following the IDEAL framework (citing any of 13 key IDEAL/IDEAL framework publications and guideline papers).

Eligibility criteria
Primary research studies of any design that involved invasive innovative devices or procedures.

Data extraction and synthesis
Study characteristics and verbatim text for all reported modifications, including contextual information, were extracted. Data were analysed and synthesised using thematic synthesis.

Results
Of 1071 records screened, 104 studies published between 2011–2023 were included (n=87 (83.6%) study reports; n=17 (16.3%) protocols). 425 modifications were reported in 76 (73.1%) studies, including modifications to procedures (n=283, 66.6%), devices (n=94, 22.1%) and patient selection (n=48, 11.3%). Procedure/device modifications included technical, non-technical and cessation (conversion to other procedures or abandonment). Modifications were most often reported within IDEAL stage 2a (n=30/44, 68.2%), whereas there was considerable variation across other stages, such as stage 0 (n=2/3, 66%) and stage 2b (n=4/12, 33.3%).

Conclusion
Reporting modifications is imperative for evaluating surgical innovation. However, this review found inconsistent approaches to reporting and describing modifications. Findings will inform the development of a checklist for reporting modifications that aims to complement the IDEAL framework and further promote shared learning, avoiding the repetition of harmful/ineffective modifications and enhancing patient safety.

PROSPERO registration number
CRD42023427704.

Objective
There are no clearly defined family profiles with an overall view of the predictors of early childhood caries (ECCs). The aim of our study was to identify the profiles of families that are particularly affected by ECCs. We also examined the factors that can be acted on to promote oral health.

Design
In this single-centre cross-sectional study, the researchers examined the mouths of 300 children with caries and recorded the Decayed, Missing and Filled Teeth Index (dmft). These observations were supplemented by a questionnaire completed by the families, focusing in particular on their sociodemographic characteristics (e.g. age, parents’ professions and jobs, social assistance and family composition).

Setting
This work was conducted at Lille University Hospital between 2019 and 2024.

Participants
The participants included 300 caregiver-child dyads with children under the age of 6 years.

Primary and secondary outcome measures
Childhood Caries Index (dmft) and family characteristics associated with ECCs.

Statistical analyses
A multiple correspondence analysis was used, followed by a hierarchical clustering on principal components analysis, to identify the family profiles associated with ECC risk.

Result
Of the patients included in the study, 42% were girls, 58% were boys and their mean age was 4 years (±1.1 years). The mean dfmt index was 8.7 (±4.6); 77% of the participants had lesions on the smooth surfaces of the teeth, and 80% of the participants had a severe stage of caries disease. The analysis revealed three high-risk profiles based on the characteristics of the child’s mother and the family sibling composition. The first profile was larger families where the focal child was not the eldest. The second profile was families with foreign-born mothers and a low socioeconomic level. The third profile was families with mothers facing geographical and financial difficulties in accessing healthcare.

Conclusion
This study enabled us to identify the profiles of families at risk of caries. These at-risk profiles highlight the need to implement specific interventions acting at different levels and focused on oral health education in interprofessional practice during the key period of the first 1000 days of life. These factors could help to bridge the gap between oral health and general health, improve children’s oral health and reduce social health inequalities.

Ethics and dissemination
This human study has been ethically approved by the French Committee for the Protection of Individuals (N° 2019-A00827-50).

Trial registration number
The protocol is recorded on clinicaltrials.gov, with ID: NCT04195607.

Objective
Prognostic nutritional index (PNI) is an index for assessing nutritional and immune status. The aim of this study is to investigate the predictive value of PNI for long-term major adverse cardiac and cerebrovascular events (MACCE) in ST-segment elevation myocardial infarction (STEMI) patients with type 2 diabetes mellitus (T2DM).

Design, setting and participants
This retrospective cohort study analysed 1582 STEMI patients with T2DM who underwent percutaneous coronary intervention from January 2015 to June 2023 in Urumqi, China. Patients were followed up for MACCE.

Primary and secondary outcome measures
The primary endpoint was new-onset MACCE including all-cause death, non-fatal MI and non-fatal stroke.

Results
This study ultimately included 1582 patients for analysis with a median follow-up period of 48 months (IQR: 24–84 months) and 282 patients (17.8%) developed MACCE. Of them, 138 (8.7%), 84 (5.3%) and 60 (3.8%) patients developed all-cause death, a non-fatal MI and a non-fatal stroke, respectively. Incidences of MACCE and all-cause death conversely correlated with PNI. Kaplan-Meier curves showed a significant difference in all components of MACCE between PNI quartiles (p

Purpose
Breastfeeding is beneficial to the health of both the mother and infant. Despite recommendations to breastfeed by organisations including the WHO and the American Academy of Pediatrics, rates of breastfeeding remain below public health goals. The Mother and Infant Metabolome and Microbiome (MIMM) study is a prospective cohort study of healthy mother-term infant dyads designed to comprehensively assess the perinatal, maternal, neonatal and infant factors that are associated with breastfeeding outcomes and human milk composition.

Participants
MIMM participants were recruited from two medical centres in Boston, Massachusetts, from 2019 to 2023 and are followed for 2 years. Dyads were included if the mother delivered a singleton infant at ≥37 weeks’ gestation, was discharged home

Objective
The objective is to explore patients’ perceptions on the management of atrial fibrillation (AF) and associated comorbidities.

Design
A descriptive qualitative study involving in-depth individual interviews, analysed using Braun and Clarke’s approach to Reflexive Thematic Analysis.

Setting
Cardiology departments in teaching hospitals in five geographically diverse European countries—Belgium, Greece, Poland, Spain and the Netherlands.

Participants
30 adults aged 65 years or older, diagnosed with AF, with two or more confirmed comorbidities were interviewed.

Results
The average age was 73 years, 37% were women and the most common comorbidity was hypertension (n=26, 87%), followed by hypercholesterolaemia (n=12, 40%), obesity (n=10, 33%), hypothyroidism (n=9, 30%) and diabetes (n=7, 23%). Three main themes were identified: (1) navigating the diagnosis path and adapting to life with AF, (2) normalising symptoms and treatment burden and (3) striving to build a therapeutic relationship.
Respondents had some knowledge about the relationship between comorbidities and AF but lacked understanding of how these comorbidities related to AF. Participants raised concerns regarding their medications, especially anticoagulants, with a desire to be given more information about them. Participants were motivated to make lifestyle adjustments but reported a lack of education and advice on how to implement and maintain these lifestyle changes. Overall, participants were very satisfied with their cardiology/AF teams, and they emphasised the importance of a person-centred approach. There was a perceived disjointedness to healthcare systems, with some reporting multiple appointments at different locations, leading to participants being frustrated and highlighting the lack of integrated care.

Conclusions
In-depth interviews provided an excellent platform to explore the perceptions and experiences of patients living with AF and associated comorbidities and highlighted the lack of an integrated approach to multimorbid AF management.

Objectives
To explore intravenous drug compatibility information needs of National Health Service (NHS) Injectable Medicines Guide (‘Medusa’) users. To develop consensus expert recommendations on the intravenous drug compatibility information that Medusa should include.

Design
A convergent parallel design. An online survey of Medusa users. A three-round Delphi project developed expert consensus.

Setting
Community, secondary, tertiary and mental healthcare sites across the UK.

Participants
142 Medusa users completed the online survey (114 nurses, 28 pharmacists). A panel of 16 nurses and 25 pharmacists currently practising in the NHS with professional expertise relevant to the compatibility of injectable medicines participated in the Delphi project.

Primary and secondary outcome measures
Users’ ratings of the importance of different types of compatibility information. Consensus expert agreement on a six-point scale regarding the compatibility information that should be provided by Medusa.

Results
97 (68%, 95% CI 60 to 75%) users were involved in the co-infusion of drugs at least weekly. Most users reported co-infusing intravenous fluids (n=116, 82%, 95% CI 75 to 87%), antibiotics (n=85, 60%, 95% CI 52 to 68%) and analgesics (n=81, 57%, 95% CI 49 to 65%) in the past year. They considered information on whether drugs are compatible/incompatible, and the concentrations and diluents in which this occurs, most important (Friedman test p

Purpose
The AMBulatoRy blOod preSsure In older Adults (AMBROSIA) study cohort was designed to determine whether ambulatory blood pressure (BP) monitoring (ABPM) is useful for identifying older adults with hypertension taking antihypertensive medication who are at increased risk for falls. The association of home BP monitoring (HBPM) with falls was assessed in an ancillary study (AMBROSIA-HOME).

Participants
AMBROSIA was a prospective observational study of adults aged 65 years and older taking antihypertensive medication for hypertension. Participants were recruited from Kaiser Permanente Southern California (KPSC), an integrated healthcare delivery system, and enrolled from May 2019 to November 2022. Demographic and clinical characteristics and geriatric assessments were collected over the course of two consecutive study visits. Participants completed a 24-hour ABPM and 1 week of HBPM. Over the following year, falls were assessed using a monthly falls calendar, and serious fall injuries were assessed from the KPSC electronic health record (EHR).

Findings to date
We enrolled 670 participants; 656 completed 24-hour ABPM and 536 also completed HBPM. The mean (SD) age of the AMBROSIA cohort was 75 (6) years, 16% were over 80 years of age and 56% were female. There were 13% non-Hispanic Asian or Pacific Islander, 22% non-Hispanic Black, 18% Hispanic and 44% non-Hispanic White participants. Nearly 72% had mild cognitive impairment, 50% were pre-frail and 4% were frail. Overall, 87% of participants returned all monthly calendars during follow-up.

Future plans
The AMBROSIA cohort can be updated with longitudinal data from the EHR including antihypertensive medication to explore the relationship of fall risk and white coat effect, defined as the difference between clinic BP and out-of-clinic BP, BP variability over 24 hours and postprandial BP decline with antihypertensive medication intensification during follow-up. Additionally, the cohort can be updated to include outcomes data from the EHR such as cardiovascular events to examine BP phenotypes as potential predictors of cardiovascular events.

Stroke, Ahead of Print. BACKGROUND:Accumulating evidence links air pollution exposure to late-life cognitive deterioration. Whether air pollution alters brain structure remains poorly understood. Thus, we aimed to quantify the association between long-term exposure to particulate matter ≤2.5 µm and ≤10 µm (PM2.5and PM10, respectively) and late-life brain structural changes.METHODS:In the Swedish National Study on Aging and Care in Kungsholmen, Stockholm, 555 participants free from dementia underwent brain magnetic resonance imaging (MRI) scans at baseline and after 6 years (cohorts 8.7 μg/m3had on average an annual shrinkage of total brain tissue volume of 0.22 (95% CI, −0.43 to −0.01) and an annual increase of 0.25 (95% CI, 0.07–0.43) of the white matter hyperintensities as compared with participants exposed to PM2.5

Background
A large proportion of individuals with coeliac disease (CeD) remain undiagnosed.

Objective
The aim of this study was to assess serological screening for CeD in the adult general population.

Design
The study was based on the fourth Trøndelag Health Study, a population-based study performed 2017–2019 in Nord-Trøndelag County, Norway, including 56 042 participants >20 years of age (54% participation rate). Serum samples were analysed with a dual antitransglutaminase 2 (TG2) IgA and IgG assay and seropositive participants were invited to endoscopy with duodenal biopsies. A CeD diagnosis was given if mucosal damage (Marsh grade 3) was found.

Results
Histological evaluation of 657 seropositive participants confirmed CeD in 423. The positive predictive value (PPV) of a positive TG2 IgA was 73.3% (95% CI 69.7% to 77.0%) for biopsy-confirmed CeD. TG2 IgA ≥10 times the upper limit of normal (ULN), as used in the no-biopsy approach in children, increased the PPV to 88.1% (95% CI 84.8% to 91.4%). Primary TG2 IgG response was found in 87 participants, five of whom had biopsy-confirmed CeD. One of the participants with CeD primarily responding with TG2 IgG was IgA deficient. The PPV of a positive TG2 IgG was 5.8% (95% CI 1.9% to 12.9%) and of TG2 IgG ≥10x ULN was 9.5% (95% CI 1.2% to 30.4%) for biopsy-confirmed CeD in TG2 IgA-negative individuals.

Conclusion
The TG2 IgA assay showed excellent abilities as a screening tool for CeD in the adult general population. However, the diagnostic accuracy of TG2 IgG was too poor for selectively identifying individuals with CeD.

Idrocefalo normoteso, malattia curabile ma poco nota. Possibili fino a 35 miliardi di euro di risparmio in un anno per il Servizio sanitario nazionale

Circulation, Ahead of Print. Background: Intramural site of origin is a major cause of ablation failure of ventricular arrhythmias and the optimal strategy is unclear. This study investigated the efficacy of a stepwise ablation approach for intramural outflow tract (OT) premature ventricular complexes (PVCs) guided by mapping of the septal coronary venous system.Methods: Consecutive patients with OT PVCs were included in which an intramural origin was confirmed by demonstration of earliest activation in a septal coronary vein. Radiofrequency ablation was performed from the closest endocardial site in the left (LVOT) and/or right ventricular OT (RVOT) independent of the local activation time. If there was no suppression by endocardial ablation, retrograde transvenous ethanol infusion with a single or double balloon technique was performed, targeting the earliest septal coronary vein. If venous anatomy was not suitable for ethanol ablation or if this failed, bipolar ablation was performed.Results: Sixty patients (age 61±12 years, 78% male) were included. The mean QRS duration of the PVC was 150.8±17.6 ms with a maximum deflection index of 0.51±0.11, and the most common ECG pattern was a left bundle branch block with inferior axis and V3 transition (63%) followed by a right bundle branch block with inferior axis and no transition (27%). Earliest ventricular activation (28.6±11.2 ms pre-QRS) was recorded in the left ventricular annular vein in 15 cases and a septal perforator vein in 45 cases. Acute PVC suppression at the end of the procedure was achieved in all cases. In 87% of cases (n=52), endocardial ablation from the endocardial LVOT, RVOT or both was successful in eliminating the PVC. In the remaining 8 patients, the PVC was eliminated with ethanol infusion (n=7) and bipolar ablation (n=1). Complications included one case of pericardial effusion related to venous mapping. During follow-up (17±24 months), the PVC burden was reduced from 28±12% to 2.3±4.7% and long-term success (≥80% burden reduction) was 88%.Conclusions: Most intramural OT PVCs can be successfully eliminated with endocardial ablation adjacent to the earliest intramural activation site. A high success rate is achieved when following a stepwise approach, with bailout ablation strategies required in a minority of cases.

Pallaroni (Assalzoo),dare più informazione soprattutto a giovani

This Teachable Moment describes an 87-year-old man who underwent fatal complications from the use of benzocaine spray for nasopharyngeal anesthesia before the insertion of a nasogastric tube.

Stroke, Ahead of Print. BACKGROUND:Recent randomized trials demonstrated the beneficial effect of endovascular therapy in patients with low Alberta Stroke Program Early Computed Tomography Score. Despite large follow-up infarct volumes, a significantly increased rate of good functional outcomes was observed, challenging the role of infarct volume as a predictive imaging marker. This analysis evaluates the extent to which the effects of endovascular thrombectomy on functional outcomes are explained by (1) follow-up infarct volume and (2) early neurological status in patients with stroke with low Alberta Stroke Program Early Computed Tomography Score.METHODS:TENSION was a randomized trial conducted from February 2018 to January 2023 across 41 stroke centers. Two hundred fifty-three patients with ischemic stroke due to anterior circulation large vessel occlusion and Alberta Stroke Program Early Computed Tomography Score of 3 to 5 were randomized to endovascular thrombectomy plus medical treatment or medical treatment alone. All patients with the availability of relevant data points were included in this secondary as-treated analysis. The primary outcome was the 90-day modified Rankin Scale score. Confounder-adjusted mediation analysis was performed to quantify the proportion of the treatment effect on a 90-day modified Rankin Scale score explained by (1) 24-hour follow-up infarct volume and (2) 24-hour National Institutes of Health Stroke Scale scores.RESULTS:One hundred eighty-eight patients were included; thereof, 87 (46%) were females. Median age was 72 (interquartile range, 63–79) years. The endovascular thrombectomy cohort had a 20.5 (95% CI, 8.3–33.7) percentage points higher probability of achieving independent ambulation (modified Rankin Scale, 0–3) and a 24.2 (95% CI, 13.4–35.8) percentage points lower mortality at 90 days compared with medical treatment alone. The reduction in 24-hour follow-up infarct volume explained 30% of the treatment effect on functional outcomes, while the 24-hour National Institutes of Health Stroke Scale score explained 61%.CONCLUSIONS:In patients with low Alberta Stroke Program Early Computed Tomography Score, infarct volume demonstrated limited explanatory power for functional outcomes compared with the early neurological status, which may more effectively reflect factors such as the involvement of specific brain regions, disruption of structural networks, and selective neuronal loss.

Objectives
Public awareness and the dissemination of tailored information to lay populations are essential for highly endemic countries like Senegal to achieve hepatitis B elimination targets by 2030. In Senegal, despite its high prevalence, hepatitis B has not received sufficient attention in health communication campaigns compared with other health issues like HIV. We aimed to explore knowledge and perceptions surrounding hepatitis B virus (HBV), as well as the influence of digital media on the information accessed by individuals living with HBV in Senegal.

Design
We employed a mixed-methods approach combining qualitative semistructured interviews conducted with people living with HBV enrolled in the Senegalese hepatitis B cohort (SEN-B), with a quantitative content analysis of online news coverage focused on HBV within the online media of Senegal.

Setting
A referral University hospital in Dakar, Senegal.

Participants
29 individuals aged >18 years presenting with a positive hepatitis B surface antigen (HBsAg) with a median age of 40 years (IQR 27–54), of whom 51.7% were female.

Outcomes and analysis
Qualitative interviews were conducted between December 2019 and October 2021, and we employed purposive sampling to select participants enrolled in SEN-B. Thematic analysis facilitated a systematic synthesis of respondents’ narratives. All data analyses were performed using Atlas.ti (V.22). For content analysis of online media news collected from September 2019 to May 2022, a structured data extraction form was developed to collect relevant information from the selected online news articles. Data on readers’ comments spaces were extracted using an inductive approach and were processed using thematic analyses. The quantitative data issued from content analysis were exported to Stata SE V.17.0 (StataCorp) for statistical analysis.

Results
We observed a generalised lack of knowledge about HBV among participants, some of whom had never heard of the virus prior to their screening. Incomprehension regarding the disease contributed to feelings of fear and anxiety, leading participants to express various concerns about their personal health status, transmission, cure and treatment(s). The presence of rumours surrounding the disease further underscored the limited awareness of HBV revealing the marginal recognition of HBV as a significant societal concern. In many cases, the absence of effective health communication strategies at the national level resulted in individuals turning to traditional and online media for information, which often intensified their fears and concerns about HBV. An analysis of Senegalese media coverage about HBV included 157 articles published between 2009 and 2022. 55.4% (87/157) of these publications appeared in July, coinciding with World Hepatitis Day, while 65.0% (102/157) focused on general HBV epidemiology and activities led by the National Hepatitis Programme. Online media also served as informal spaces where unaccredited actors within the health sector promoted treatments lacking official verification. Additionally, the reactions’ spaces provided a venue for the exchange of information, though without any guarantee of its accuracy.

Conclusions
Facilitating collaboration and engagement between health communication stakeholders and communities is crucial for effectively disseminating structured information and culturally appropriate messages, ultimately contributing to raising awareness of HBV.

Objectives
To feasibility test a novel community-based financial incentive scheme to promote healthy weight and well-being.

Design
Single-arm, prospective feasibility study using mixed methods.

Setting
Two communities in Scotland experiencing high levels of disadvantage according to the Scottish Index for Multiple Deprivation (SIMD). Community C1 is in a large rural area with a small town centre (population~1.5K) and community C2 is a small and urban community (population~9K), enabling contextual comparison.

Participants
Eligible adult (18 years or over) community members recruited through community outreach.

Intervention
The Enjoy Life LocallY (ELLY) intervention comprised free soup twice weekly (café/delivery/pickup); loyalty card stamped for engagement in community assets (such as local activities, groups and clubs) exchanged for a £25 shopping card when a participant attends a minimum of 9 assets over 12 weeks; goal setting; information resources; self-monitoring of weight and well-being.

Outcomes
Primary outcomes—feasibility of recruitment, retention and engagement. Acceptability of intervention components was assessed by self-reported questionnaires and interviews. Secondary outcomes—feasibility of collecting outcomes prioritised by communities for a future trial: health-related quality of life (EQ-5D-5L), mental well-being (WEMWBS), connectedness (Social Connectedness Scale) and weight-related measures (weight, body mass index (BMI)).

Results
Over 3 months, 75 community citizens (35 citizens in C1, 40 citizens in C2) were recruited (125% of target recruitment of 60 participants (117% of 30 participants C1 target, 133% of 30 participants C2 target), 84% female, baseline weight mean (SD)=84.8 kg (20) and BMI mean (SD)=31.9 kg/m2 (7.3), 65/75 (87%) living in disadvantaged areas (SIMD quintiles 1–3)). Retention at 12 weeks, defined by completion of outcome measures at 12 weeks, was 65 (87%). Participation in at least one asset for a minimum of 9 out of 12 weeks of the intervention was achieved by 55 (73%). All intervention components were acceptable, with the loyalty card being the most popular and the soup cafés the least popular. The mean average cost of the soup ingredients, per participant, over the 12 weeks was £12.02. Outcome data showed a small decrease in weight and BMI and a small increase in health-related quality of life, mental well-being and social connectedness.

Conclusions
The ELLY study recruited and retained participants from two disadvantaged communities in Scotland. The study was acceptable to participants and feasible to deliver. A full trial is warranted to determine effectiveness and cost-effectiveness, with consideration of scalability.

Trial registration number
The ELLY feasibility study was not pre-registered.